RecruitingPhase 2NCT06685796

A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer

A Phase II Study of BEBT-209 in Combination With Carboplatin and Gemcitabine for the Treatment of Advanced Triple-Negative Breast Cancer


Sponsor

BeBetter Med Inc

Enrollment

120 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new drug called BEBT-209 combined with chemotherapy (carboplatin and gemcitabine) in women with triple-negative breast cancer — a type that lacks hormone receptors and HER2 — that has come back or spread after 1–2 prior treatments. **You may be eligible if...** - You are a woman aged 18 or older - You have been confirmed to have triple-negative (HR-negative, HER2-negative) breast cancer that is locally advanced or metastatic - Your cancer has received 1–2 prior lines of treatment - You have at least one measurable tumor on a scan - You are physically functional (ECOG 0–1) - Your blood counts and organ function are in an acceptable range **You may NOT be eligible if...** - You have previously been treated with gemcitabine - You have brain metastases requiring immediate treatment - You have had a bone marrow or stem cell transplant - You have a history of serious heart problems - You are pregnant or breastfeeding - You have active hepatitis B, hepatitis C, or HIV Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBEBT-209 capsules

BEBT-209 Capsules, dosage: 150mg, frequency and duration of administration: administered on days 1, 2, 8, and 9 of each cycle, with a 21-day cycle. On days 1 and 8, take orally once before dinner or twice (before breakfast and before dinner), and on days 2 and 9, take orally once before breakfast.

DRUGCarboplatin injection

Carboplatin injection, dosage: AUC 2 × (creatinine clearance rate + 25), frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.

DRUGGemcitabine hydrochloride for injection

Gemcitabine hydrochloride for injection, dosage: 1000mg/m², frequency and duration of administration: administered on days 1 and 8 or days 2 and 9 of each cycle, with a 21-day cycle.


Locations(2)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Hunan Cancer Hospital

Changsha, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT06685796